Study shows reteplase superior to alteplase within 4.5 hours of ischemic stroke

Reteplase is noninferior to alteplase for patients with ischemic stroke within 4.5 hours after symptom onset, according to a study published online June 14 in the New England Journal of Medicine to coincide with the 10th Annual Conference of the Chinese Stroke Association & Tiantan International Stroke Conference 2024, held from June 14 to 16 in Beijing.

Shuya Li, M.D., from Beijing Tiantan Hospital, and colleagues randomly assigned patients with ischemic stroke within 4.5 hours after symptom onset to receive intravenous reteplase (bolus of 18 mg followed by a second bolus of 18 g 30 minutes later) or intravenous alteplase (0.9 mg/kg body weight up to a maximum of 90 mg; 707 and 705 patients, respectively).

The researchers found that 79.5 and 70.4% of patients in the reteplase and alteplase groups, respectively, had an excellent functional outcome (risk ratio, 1.13; 95% confidence interval, 1.05 to 1.21; P < 0.001 for noninferiority and P = 0.002 for superiority). Symptomatic intracranial hemorrhage within 36 hours after disease onset occurred in 2.4 and 2.0% of patients in the reteplase and alteplase groups, respectively (risk ratio, 1.21; 95% confidence interval, 0.54 to 2.75).

The incidence of any intracranial hemorrhage at 90 days was 7.7 versus 4.4% with reteplase versus alteplase (risk ratio, 1.59; 95% confidence interval, 1.00 to 2.51), and the incidence of adverse events was 91.6 versus 82.4% (risk ratio, 1.11; 95% confidence interval, 1.03 to 1.20).

“The RAISE trial showed that intravenous reteplase was noninferior to intravenous alteplase in achieving an excellent functional outcome,” the authors write.

The study was funded by China Resources Angde Biotech Pharma.

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